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A First-in-Human Study of FID-022 in Solid Tumor Patients
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Summary
This observational study aims to (1) validate a multimodal artificial intelligence (AI) model for early detection of cancer-associated cachexia in pancreatic cancer patients and (2) assess the feasibility and acceptability of diet and exercise interventions for cachexia management. The study will use retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center.
Official title: AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-10-08
Completion Date
2026-10
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
Baseline Lifestyle and Symptom Assessment
Dietary questionnaire (VioScreen), symptom and QoL surveys (ESAS-r, FAACT, PROMIS PF, PG-SGA), physical activity survey (Modified GLTEQ), functional fitness tests, DEXA scans, blood draws.
Extended Lifestyle Monitoring
Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.
Feasibility Survey
One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.
Locations (1)
Moffitt Cancer Center
Tampa, Florida, United States